Hepatocellular Carcinoma (HCC)CENTINELNCT07265271
Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)
An observational study of Hepatocellular Carcinoma (HCC), run by City of Hope Medical Center at 1 site in United States.
Trial summary
Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Small RNA sequence and Rt-qPCR
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 18 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who were diagnosed with hepatocellular carcinoma. Individuals who were diagnosed with chronic liver disease Healthy donors
Who may be able to join
- Adults aged 18 to 100 years.
- A histologically confirmed diagnosis of hepatocellular carcinoma.
- A clinically diagnosed as chronic liver disease, including chronic hepatitis or liver cirrhosis, without evidence of hepatocellular carcinoma.
- Healthy volunteers without known liver disease or malignancy.
- Received standard diagnostic and staging procedures as per local guidelines
- Availability of blood or other biospecimens.
- Ability to provide written informed consent.
Who cannot join
- Lack of or inability to provide informed consent
- History of other active malignancies within the past 5 years
- Previous liver transplantation
- Severe systemic infection or inflammatory disease at the time of enrollment
- Inadequate sample quality or quantity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91016
Ajay Goel, PhD, 626-218-3452, ajgoel@coh.org
About this study
Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited.
This study seeks to develop a multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.
Read the detailed description
Liver cancer is a major global health challenge, ranking as the 5th leading cause of cancer-related deaths in the U.S. and 3rd worldwide, with hepatocellular carcinoma (HCC) accounting for ~75% of cases. Incidence has more than tripled since 1980, and death rates have risen by ~2% annually, highlighting the need for improved detection and treatment. Prognosis remains poor: over 50% of HCC cases are diagnosed at stage IV, with a 1-year survival below 30%, whereas early-stage HCC (stages I-II) can achieve up to 74% 5-year survival with curative interventions. Major risk factors include viral hepatitis (HBV, HCV), alcohol abuse, obesity, type 2 diabetes, and non-alcoholic fatty liver disease (NAFLD), with non-viral HCC increasing in prevalence, particularly in Western countries. Screening programs target high-risk populations but miss many asymptomatic or average-risk individuals, contributing to late-stage diagnoses.
Biomarker discovery holds promise for improving early detection. Alpha-fetoprotein (AFP), the most widely used biomarker, has limited sensitivity for early-stage HCC (39-64%).
This study seeks to validate a panel of more accurate and non-invasive biomarkers in preoperative blood samples. Accurate early detection of HCC would help provide clear criteria for treatment decisions, such as timely surgical intervention or the addition of adjuvant chemotherapy.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Small RNA sequence, Rt-qPCR
- Keywords
- HCC, Liver cancer, tsRNA, Liquid Biopsy, Early Detection
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small RNA sequenceDiagnostic test
Comprehensive small RNA sequencing of serum or plasma-derived cf-tsRNAs to identify candidate biomarkers distinguishing HCC from NDC.
Rt-qPCRDiagnostic test
Construction of integrated cf- tsmiRNAs diagnostic classifier using machine learning
Rt-qPCRDiagnostic test
PCR-based validation of the tsRNA panel
| Study group | Role | What they receive |
|---|---|---|
| HCC (Discovery, Small RNA-seq) | Patient diagnosed with hepatocellular carcinoma, including cases with HBV-, HCV-, and NBNC-related etiologies. Blood or other biospecimens will be collected for multi-omics profiling Receives: Diagnostic Test: Small RNA sequence; Diagnostic Test: Rt-qPCR | |
| Chronic Liver Disease (CLD) cohort | Patients with chronic liver disease, including liver cirrhosis and chronic hepatitis, without evidence of hepatocellular carcinoma.
Blood or other biospecimens will be collected for multi-omics profiling. Receives: Diagnostic Test: Small RNA sequence; Diagnostic Test: Rt-qPCR | |
| Healthy Controls | Healthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation. Receives: Diagnostic Test: Small RNA sequence; Diagnostic Test: Rt-qPCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the integrated multi-omics signature for hepatocellular carcinoma detection
To evaluate the diagnostic accuracy of the model for distinguishing patients with hepatocellular carcinoma from chronic liver disease and healthy controls, as assessed by the area under the operating characteristic curve (AUC), sensitivity, and specificity.
Measured: At the baseline
Secondary outcomes (2)
Validation of the diagnostic model in independent cohorts
To assess the reproducibility and generalizability of the diagnostic model using independent validation cohorts.
Measured: At the baseline
Identification of etiology-associated omics profiles in hepatocellular carcinoma
To characterize differences in omics patterns among HBV-, HCV-, and NBNC-related hepatocellular carcinoma cases, using integrated high-throughput multi-omics analysis.
Measured: At the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Jan 2025
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265271
- Sponsor's protocol ID
- 23228/CENTINEL
- Acronym
- CENTINEL
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.
Publications
Shao Y, Yu X, Zhou W, Yan J, Dong H, Ye G. Biological roles and potential clinical value of tRNA-derived small RNAs in gastrointestinal malignancies. Ann Med. 2025 Dec;57(1):2566866. doi: 10.1080/07853890.2025.2566866. Epub 2025 Oct 9.
PubMed 41069160Mao M, Chen W, Huang X, Ye D. Role of tRNA-derived small RNAs(tsRNAs) in the diagnosis and treatment of malignant tumours. Cell Commun Signal. 2023 Jul 21;21(1):178. doi: 10.1186/s12964-023-01199-w.
PubMed 37480078Lee S, Kim J, Valdmanis PN, Kim HK. Emerging roles of tRNA-derived small RNAs in cancer biology. Exp Mol Med. 2023 Jul;55(7):1293-1304. doi: 10.1038/s12276-023-01038-5. Epub 2023 Jul 10.
PubMed 37430089Zhou M, He X, Zhang J, Mei C, Zhong B, Ou C. tRNA-derived small RNAs in human cancers: roles, mechanisms, and clinical application. Mol Cancer. 2024 Apr 15;23(1):76. doi: 10.1186/s12943-024-01992-2.
PubMed 38622694Yuan J, Gu WC, Xu TX, Shen XJ, Li X, Shen L, Zhang Y, Ju SQ. 5'-transfer RNA halve-lysine-CTT as a promising biomarker for early detection of hepatocellular carcinoma. World J Gastrointest Oncol. 2025 Nov 15;17(11):111142. doi: 10.4251/wjgo.v17.i11.111142.
PubMed 41281472Sauzay C, Petit A, Bourgeois AM, Barbare JC, Chauffert B, Galmiche A, Houessinon A. Alpha-foetoprotein (AFP): A multi-purpose marker in hepatocellular carcinoma. Clin Chim Acta. 2016 Dec 1;463:39-44. doi: 10.1016/j.cca.2016.10.006. Epub 2016 Oct 11.
PubMed 27732875Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.
PubMed 33479224Xing H, Zheng YJ, Han J, Zhang H, Li ZL, Lau WY, Shen F, Yang T. Protein induced by vitamin K absence or antagonist-II versus alpha-fetoprotein in the diagnosis of hepatocellular carcinoma: A systematic review with meta-analysis. Hepatobiliary Pancreat Dis Int. 2018 Dec;17(6):487-495. doi: 10.1016/j.hbpd.2018.09.009. Epub 2018 Sep 15.
PubMed 30257796Choi JY, Jung SW, Kim HY, Kim M, Kim Y, Kim DG, Oh EJ. Diagnostic value of AFP-L3 and PIVKA-II in hepatocellular carcinoma according to total-AFP. World J Gastroenterol. 2013 Jan 21;19(3):339-46. doi: 10.3748/wjg.v19.i3.339.
PubMed 23372355Xu J, Chen B, Qi J, Wu J, Feng W, Jin K, Bao H, Chen L, Wang F. Evaluation of serum hsa_tsr014055 as a potential biomarker for diagnosis and prognosis of hepatocellular carcinoma. Ann Med. 2025 Dec;57(1):2528978. doi: 10.1080/07853890.2025.2528978. Epub 2025 Jul 6.
PubMed 40618217Jin K, Wu J, Yang J, Chen B, Xu J, Bao H, Zong W, Xie C, Chen L, Wang F. Identification of serum tsRNA-Thr-5-0015 and combined with AFP and PIVKA-II as novel biomarkers for hepatocellular carcinoma. Sci Rep. 2024 Nov 21;14(1):28834. doi: 10.1038/s41598-024-80592-y.
PubMed 39572775
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)
- ClinicalTrials.gov ID
- NCT07265271
- Acronym / sponsor ID
- CENTINEL / 23228/CENTINEL
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC, Liver cancer, tsRNA, Liquid Biopsy, Early Detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited.
This study seeks to develop a multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.
Detailed description
Liver cancer is a major global health challenge, ranking as the 5th leading cause of cancer-related deaths in the U.S. and 3rd worldwide, with hepatocellular carcinoma (HCC) accounting for ~75% of cases. Incidence has more than tripled since 1980, and death rates have risen by ~2% annually, highlighting the need for improved detection and treatment. Prognosis remains poor: over 50% of HCC cases are diagnosed at stage IV, with a 1-year survival below 30%, whereas early-stage HCC (stages I-II) can achieve up to 74% 5-year survival with curative interventions. Major risk factors include viral hepatitis (HBV, HCV), alcohol abuse, obesity, type 2 diabetes, and non-alcoholic fatty liver disease (NAFLD), with non-viral HCC increasing in prevalence, particularly in Western countries. Screening programs target high-risk populations but miss many asymptomatic or average-risk individuals, contributing to late-stage diagnoses.
Biomarker discovery holds promise for improving early detection. Alpha-fetoprotein (AFP), the most widely used biomarker, has limited sensitivity for early-stage HCC (39-64%).
This study seeks to validate a panel of more accurate and non-invasive biomarkers in preoperative blood samples. Accurate early detection of HCC would help provide clear criteria for treatment decisions, such as timely surgical intervention or the addition of adjuvant chemotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCC (Discovery, Small RNA-seq) | – | Diagnostic Test: Small RNA sequence, Diagnostic Test: Rt-qPCRPatient diagnosed with hepatocellular carcinoma, including cases with HBV-, HCV-, and NBNC-related etiologies. Blood or other biospecimens will be collected for multi-omics profiling |
| Chronic Liver Disease (CLD) cohort | – | Diagnostic Test: Small RNA sequence, Diagnostic Test: Rt-qPCRPatients with chronic liver disease, including liver cirrhosis and chronic hepatitis, without evidence of hepatocellular carcinoma. Blood or other biospecimens will be collected for multi-omics profiling. |
| Healthy Controls | – | Diagnostic Test: Small RNA sequence, Diagnostic Test: Rt-qPCRHealthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who were diagnosed with hepatocellular carcinoma. Individuals who were diagnosed with chronic liver disease Healthy donors
Key inclusion criteria (7 listed)
- Adults aged 18 to 100 years.
- A histologically confirmed diagnosis of hepatocellular carcinoma.
- A clinically diagnosed as chronic liver disease, including chronic hepatitis or liver cirrhosis, without evidence of hepatocellular carcinoma.
- Healthy volunteers without known liver disease or malignancy.
- Received standard diagnostic and staging procedures as per local guidelines
Key exclusion criteria (5 listed)
- Lack of or inability to provide informed consent
- History of other active malignancies within the past 5 years
- Previous liver transplantation
- Severe systemic infection or inflammatory disease at the time of enrollment
- Inadequate sample quality or quantity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small RNA sequenceComprehensive small RNA sequencing of serum or plasma-derived cf-tsRNAs to identify candidate biomarkers distinguishing HCC from NDC. | Diagnostic test | Chronic Liver Disease (CLD) cohort, HCC (Discovery, Small RNA-seq), Healthy Controls |
| Rt-qPCRConstruction of integrated cf- tsmiRNAs diagnostic classifier using machine learning | Diagnostic test | Chronic Liver Disease (CLD) cohort, HCC (Discovery, Small RNA-seq), Healthy Controls |
| Rt-qPCRPCR-based validation of the tsRNA panel | Diagnostic test | Chronic Liver Disease (CLD) cohort, HCC (Discovery, Small RNA-seq), Healthy Controls |
Primary outcome
Diagnostic performance of the integrated multi-omics signature for hepatocellular carcinoma detection
Time frame: At the baseline
To evaluate the diagnostic accuracy of the model for distinguishing patients with hepatocellular carcinoma from chronic liver disease and healthy controls, as assessed by the area under the operating characteristic curve (AUC), sensitivity, and specificity.
2 secondary outcomes
Validation of the diagnostic model in independent cohorts
Time frame: At the baseline
Identification of etiology-associated omics profiles in hepatocellular carcinoma
Time frame: At the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 41069160Shao Y, Yu X, Zhou W, Yan J, Dong H, Ye G. Biological roles and potential clinical value of tRNA-derived small RNAs in gastrointestinal malignancies. Ann Med. 2025 Dec;57(1):2566866. doi: 10.1080/07853890.2025.2566866. Epub 2025 Oct 9.
- Background: PubMed 37480078Mao M, Chen W, Huang X, Ye D. Role of tRNA-derived small RNAs(tsRNAs) in the diagnosis and treatment of malignant tumours. Cell Commun Signal. 2023 Jul 21;21(1):178. doi: 10.1186/s12964-023-01199-w.
- Background: PubMed 37430089Lee S, Kim J, Valdmanis PN, Kim HK. Emerging roles of tRNA-derived small RNAs in cancer biology. Exp Mol Med. 2023 Jul;55(7):1293-1304. doi: 10.1038/s12276-023-01038-5. Epub 2023 Jul 10.
- Background: PubMed 38622694Zhou M, He X, Zhang J, Mei C, Zhong B, Ou C. tRNA-derived small RNAs in human cancers: roles, mechanisms, and clinical application. Mol Cancer. 2024 Apr 15;23(1):76. doi: 10.1186/s12943-024-01992-2.
- Background: PubMed 41281472Yuan J, Gu WC, Xu TX, Shen XJ, Li X, Shen L, Zhang Y, Ju SQ. 5'-transfer RNA halve-lysine-CTT as a promising biomarker for early detection of hepatocellular carcinoma. World J Gastrointest Oncol. 2025 Nov 15;17(11):111142. doi: 10.4251/wjgo.v17.i11.111142.
- Background: PubMed 27732875Sauzay C, Petit A, Bourgeois AM, Barbare JC, Chauffert B, Galmiche A, Houessinon A. Alpha-foetoprotein (AFP): A multi-purpose marker in hepatocellular carcinoma. Clin Chim Acta. 2016 Dec 1;463:39-44. doi: 10.1016/j.cca.2016.10.006. Epub 2016 Oct 11.
- Background: PubMed 33479224Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.
- Background: PubMed 30257796Xing H, Zheng YJ, Han J, Zhang H, Li ZL, Lau WY, Shen F, Yang T. Protein induced by vitamin K absence or antagonist-II versus alpha-fetoprotein in the diagnosis of hepatocellular carcinoma: A systematic review with meta-analysis. Hepatobiliary Pancreat Dis Int. 2018 Dec;17(6):487-495. doi: 10.1016/j.hbpd.2018.09.009. Epub 2018 Sep 15.
- Background: PubMed 23372355Choi JY, Jung SW, Kim HY, Kim M, Kim Y, Kim DG, Oh EJ. Diagnostic value of AFP-L3 and PIVKA-II in hepatocellular carcinoma according to total-AFP. World J Gastroenterol. 2013 Jan 21;19(3):339-46. doi: 10.3748/wjg.v19.i3.339.
- Background: PubMed 40618217Xu J, Chen B, Qi J, Wu J, Feng W, Jin K, Bao H, Chen L, Wang F. Evaluation of serum hsa_tsr014055 as a potential biomarker for diagnosis and prognosis of hepatocellular carcinoma. Ann Med. 2025 Dec;57(1):2528978. doi: 10.1080/07853890.2025.2528978. Epub 2025 Jul 6.
- Background: PubMed 39572775Jin K, Wu J, Yang J, Chen B, Xu J, Bao H, Zong W, Xie C, Chen L, Wang F. Identification of serum tsRNA-Thr-5-0015 and combined with AFP and PIVKA-II as novel biomarkers for hepatocellular carcinoma. Sci Rep. 2024 Nov 21;14(1):28834. doi: 10.1038/s41598-024-80592-y.
- Individual participant dataSharing planned: No. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Goel Ajay, PhD (626-218-3452, ajgoel@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the integrated multi-omics signature for hepatocellular carcinoma detection (time frame: At the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07265271, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.